Britannia v Ever Pharma: Dacepton leavepieces ruled misleading on stability and cost-saving claims (AUTH/3275/10/19)

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Key facts

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Case	AUTH/3275/10/19
Parties	Britannia Pharmaceuticals v Ever Pharma
Medicine	Dacepton (apomorphine for injection)
Indication (as stated)	Treatment of motor fluctuations (‘on-off’ phenomena) in patients with Parkinson’s disease not sufficiently controlled by oral anti-Parkinson medication
Presentations (as stated)	10mg/ml cartridge for injection; 5mg/ml solution for infusion
Materials	Email from nurse advisor; leavepiece EVP-091 (5mg/ml pump); leavepiece EVP-090 (10mg/ml cartridge)
Main upheld issues	Unqualified stability claims (7 days / 15 days) omitting microbiological contamination caveat; cost-saving claims not sufficiently complete and, in context, incapable of substantiation; omission of “as needed” dosing context in cost model
Breach clauses	3.2, 7.2, 7.3, 7.4, 7.10
No breach clauses (listed)	2, 4.3, 7.2, 7.4, 7.8, 8.1, 9.1, 9.9, 12.1, 14.1, 16.3, 18.1
Complaint received	24 October 2019
Case completed	31 August 2021
Appeal	No appeal (appeal from Ever was subsequently withdrawn)
Sanction	Undertaking received
Applicable Code year	2019

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Complainant: Britannia Pharmaceuticals complained about Ever Pharma’s promotion of Dacepton (apomorphine) for Parkinson’s disease motor fluctuations.
Materials at issue:
- An email from an Ever Pharma nurse advisor to a health professional (alleged unsolicited/disguised promotion and package deal concerns).
- Leavepiece for Dacepton Pump 5mg/ml (ref EVP-091, Sept 2019).
- Leavepiece for Dacepton Cartridge 10mg/ml (ref EVP-090).
Core theme of upheld issues: promotional claims about in-use stability and cost savings relied on stability periods (7 days / 15 days) but omitted the SPC’s microbiological contamination caveat (“should be used immediately” unless handling precludes contamination), and in one instance omitted key context about “as needed” dosing.
Email allegation outcome driver: the Panel had not seen the unredacted email trail and could not determine whether it was solicited; the complainant did not meet the burden of proof.

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No breach was ruled for the nurse email allegations (including claims it was unsolicited promotional email, lacked prescribing information, lacked consent, disguised promotion, exam requirement, and package deal not bona fide).
No breach was ruled for:
- Allegation that pump imagery was misleading as to size.
- Allegation that describing APO-go administration as a “20ml syringe driver” was misleading/disparaging.
- Allegation that D-mine pump features implied only Ever Pharma had a specifically designed pump for apomorphine infusion.
- Allegation of disparagement regarding the APO-go pen safety stop comparison (though the comparison was still found misleading).
Breaches were ruled where stability and cost-saving claims were misleading/incomplete and/or incapable of substantiation in context.

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